JP6010409B2 - Working with sample tubes with geometric tube data - Google Patents

Description

  The present invention relates to the field of in-vitro diagnosis, and more particularly to a system and method for automatic manipulation of biological samples.

  Clinical laboratories are faced with the challenge of increasing the throughput per day while ensuring that the analytical results obtained from the samples are reproducible and accurate. Errors can occur at any of the pre-analysis, post-analysis, and post-analysis stages that can result in a highly complex sample processing workflow. A further challenge is that there are a huge variety of different sample types, making sample manipulation and automated processing more complex. In one aspect, the diversity of sample tubes is due to the diversity of sample processing workflows and tests that have been developed for various diagnostic, analytical, or other purposes.

  In other aspects, to collect and process various types of biological samples (eg, blood, urine, serum, or plasma samples) and / or various types of analytical tests (coagulation tests, clinical chemistry tests, blood The aforementioned diversity is attributed to various sample manufacturers that use various materials, sample tube dimensions, cap color codes, for example).

  In order to meet the requirements for analytical quality and cost efficiency, there is a need for sensible solutions in the field of automated sample handling equipment.

  Current pre-analysis and post-analysis systems and analyzers require information about tube geometry, sample type, target volume, cap type, etc. in order to accurately manipulate and process the sample tube. In current systems, this information must be collected by cameras and / or sensors or determined manually by the user. However, any steps that are performed manually are error prone and time consuming and are therefore not suitable for performing a high quality sample processing workflow. Techniques based on image analysis are often time consuming and can cause errors. Errors can occur when it is necessary to process frozen or strongly cooled samples that have frozen surfaces or contain condensed water. Ice and water can change the shape and optical parameters of the sample tube and can cause errors when images are obtained from such samples for image analysis. Also, if the tube is placed at an angle rather than vertical in the rack, an error may be caused by a light source that is too weak for the camera to reliably detect the color of the tube or tube cap. Errors can be caused by pipes protruding from the pipe rack or other sources of errors. For example, Patent Document 1 discloses a sample container operating device provided with a camera. The camera takes a picture from the loaded sample and compares the image of the sample tube in the image library with the photograph taken to determine the type of tube in the loaded sample container.

  U.S. Patent No. 6,053,077 discloses an assay test diagnostic analyzer system that includes a mounting bay carrying a plurality of carriers configured to hold a container containing a fluid material for use in a diagnostic process. A barcode reader in the system reads barcoded labels attached to the carrier and sample tubes or reagent bottles as the robotic device passes the carrier near the reader. In operation, the robotic arm lifts the carrier from the mounting rack and moves it past the barcode reader to identify the carrier and sample.

US Pat. No. 6,599,476 US Pat. No. 7,458,483

  It is an object of embodiments of the present invention to provide improved methods, sample tubes and sample tube manipulation systems. This object is solved by the features of the independent claims. Embodiments of the invention are given by the dependent claims.

  A “sample” or “biological sample” includes any type of tissue or fluid obtained from the human body or other organism. In particular, the biological sample can be a whole blood, serum, plasma, urine, cerebrospinal fluid, or saliva sample, or a derivative thereof.

  A “sample tube”, also referred to herein as a “tube”, in accordance with the present invention, receives a sample such as a blood sample from a patient and transfers the sample contained therein to an analytical laboratory for diagnostic purposes. Either a sample collection test tube, also referred to as a “first tube”, or a “second tube” that can be used to receive a dispensed dose from the first tube. The first sample tube is typically made of glass or resin and has a closed end and an open end, and the open end is closed by a cap. The cap can be of different materials, shapes, and colors. Cap shape and / or color, and / or tube shape and / or color can indicate the type of tube, the type of biological sample contained therein, and / or the analysis performed on the sample. It can indicate which procedure is before, during or after the analysis. For example, there are a tube containing an anticoagulant or a coagulation inducer, a tube containing a plasma separation promoting gel, and the like. Often, different types of first tubes are simply the result of customization by different first tube manufacturers. In particular, there is a first tube having a different diameter and / or a different depth to contain different amounts of sample. The second tube is typically made of resin and may have a smaller degree of size and type change relative to the first tube. In particular, the second tube may be smaller than the first tube and may be designed to be closed with a similar closure member type, such as a screw-type closure member.

  As used herein, the term “cap” refers to any type of closure member, including a screw-type cap and a rubber stopper, that can be opened and / or closed by a push-pull action and / or a screw action, respectively. Including.

  As used herein, a “robot unit” may be any type of device or device part that can automatically perform sample workflow steps in a sample tube.

  The expression “tube type” refers to a category of sample tubes that are characterized by a common geometric structure, such as in particular the width, geometry and / or height of the cap and / or tube. In general, but not necessarily, the common geometric structure of a sample tube corresponds to the common sample type carried by that sample tube type and / or is performed on a sample of that tube type , Corresponding to common types of workflow steps before or after analysis. Different tube types are typically adapted to different conditions under analysis before, after and after a particular analysis or workflow step, such as clinical chemistry analysis, hematology analysis or coagulation analysis. Confusion of sample tube types can make it impossible to use a sample for a scheduled analysis. To prevent errors in sample collection and operation, many tube manufacturers' sample caps are encoded with a uniform color scheme.

  A “processing device” or “work cell” is a stand-alone device or a module within a large device that assists the user with sample processing. “Sample processing” refers to sample detection and / or sample classification and / or preparation prior to detection, or sample after detection, eg, qualitative and / or quantitative evaluation of a sample for diagnostic purposes. Including storage and / or disposal. In particular, a work cell may be associated with an analytical sample processing step and / or a pre-analytical sample processing step and / or a post-analytical sample processing step, which are collectively referred to herein as “in vitro. ) ”Step. Workcells can be connected to each other and are at least partially dependent on each other. For example, each performs a dedicated role in the sample processing workflow that may be a prerequisite before proceeding to the next work cell. Alternatively, the work cells may operate independently of each other, and each may perform a separate role, eg, different types of analysis. The “processing device” may be, for example, a cap unit, a cap removal unit, a dispenser, a centrifuge, and the like.

  In one aspect, the present invention relates to a method for manipulating a sample tube containing a biological sample. A tube label is attached to the sample tube, and the tube label holds the tube data. The tube data includes at least geometric data representing at least one geometric characteristic of the sample tube. The method comprises the steps of reading at least geometric tube data from a tube label with a reader, transmitting at least geometric tube data from the reader to a processor, and reading the geometric data. Controlling a processing device for manipulating the sample tube in accordance with the represented at least one geometric characteristic.

  These features are advantageous because providing the sample tube with the geometric tube data of the biological sample tube ensures that the geometric data is available throughout the sample processing workflow. In prior art systems using a color coded cap to identify the sample tube type, tube type information may be lost when the cap is removed from the sample tube. By providing geometric data in the sample tube, fully automated sample processing is ensured and no information about geometric properties is lost from the uncapped tube. Therefore, the speed and cost efficiency of the sample manipulation workflow is improved and the susceptibility to error of the sample manipulation process is reduced.

  In other words, the geometric data as the data actually required for fully automated processing is an inherent part of the tube and is never lost. According to another embodiment, the tube type identifier is provided on the tube label in addition to the geometric data and / or obtained in a second step from the geometric data read from the tube label. By obtaining the tube type from the geometric data (rather than by obtaining the geometric data from the detected tube type as in prior art systems), for example, the cap from the tube of the tube When removed, it is ensured that no pipe type information is lost. The tube type according to some embodiments is derived from geometric data and not vice versa, the geometric tube data being available at any time, regardless of its cap status. Safe levels are added to the system.

  In another advantageous aspect, embodiments of the present invention identify a particular sample type in a first step (eg, based on a color type or based on a tube type identifier printed on a sample tube). ) Step can be skipped, and geometric data for identifying the type of sample tube can be collected in the second step. By reading the geometric properties directly from the tube label, the processing time required to collect the geometric data required for the sample handling unit is reduced. In addition, the acquisition of geometric data makes it more resistant to errors. This is because the geometric information is obtained directly from the sample tube, not indirectly from an external storage device storing geometric data associated with the sample tube identifier. Thus, embodiments of the present invention do not need to maintain a database storing sample type identifiers with corresponding geometric data or to maintain a connection to the database. Maintaining such a database is often impossible in the first place because sample collection and testing is done at different locations and by different institutions.

  In another advantageous aspect, embodiments of the present invention are much more flexible because the geometric properties of the majority of sample tubes can be determined dynamically. Therefore, general-purpose sample manipulation work cell components can be used and are not limited to those of a specific type of sample tube or a specific sample manufacturer. Therefore, the general-purpose sample tube operation component can be combined with any kind of pre-analysis sample operation work cell, analysis sample operation work cell, post-analysis sample operation work cell, and parts thereof. This is because these components can work with any type of sample tube if the sample tube is provided with a label identifying the geometric data of the sample tube.

  In another advantageous aspect, embodiments of the present invention can utilize the geometric data required by the device for manipulating the sample whenever a particular biological sample reaches the input position of the sample manipulating device. Is guaranteed. In prior art systems, the operation of a complex automatic sample work cell may be interrupted when a sample of the wrong or unknown sample type is accidentally placed in the sample processing pipeline. This is because no geometric data could be found for samples of unknown sample type. Required to determine how and how a sample tube should be operated by a specific sample handling device by using a sample tube with the respective geometric data on the label Ensure that all information is available at all times. Therefore, it is possible to prevent a failure in the processing workflow caused by an unidentified tube type.

  In addition, the disadvantages of camera-based systems, particularly inaccurate determination of tube structure, inaccurate determination of sample volume due to not knowing the internal structure of the tube, and tube rotation or non-rotation due to sample opacity Can prevent inaccurate determination. It has been found that the camera-based cap color determination used to determine the tube type used to determine the tube structure is prone to errors, and tube type information is lost when the cap is removed.

  In another advantageous aspect, according to embodiments of the present invention, periodic tube type library updates are not required. If, for example, a pipe manufacturer produces a completely new type of pipe whose geometric characteristics, such as its diameter, are stored or encoded in the pipe label, the processing device according to an embodiment of the present invention It does not need to be reprogrammed to “identify” the type. This is because the geometric data actually used for processing the sample tube is obtained directly from the tube label. Thus, the processor does not need to access the tube type library and retrieve the stored geometric data associated with the identified sample type, and therefore periodically retrieve such tube type library. There is no need to update. In summary, embodiments of the present invention maintain a tube type library and allow sample manipulation to automatically determine the required geometric properties of any tube type without searching (querying). The system can be developed and operated. What kind of tube label with geometric tube data encoded so that the reader can read the data, when installed by the tube manufacturer or by another example New sample tube types are immediately and automatically recognizable and processable by the sample handling system. There is no need to update the sample tube type library with new tube types developed by tube manufacturers.

  As used herein, the term “geometric tube data” includes any data that indicates the geometric properties of the entire tube or a portion of the tube, in particular the tube shaft and / or the cap of the tube. Or data indicating the geometric properties of these combinations.

  According to an embodiment, the geometric characteristics are encoded according to a barcode encoding standard such as PDF417, Codebloc, etc. This means that if the tube type manufacturer and the sample processing device manufacturer use the same encoding / decoding standard, the workcell based on that encoding scheme will be either the tube manufacturer or the other tube manufacturer. Such tube types are advantageous in that they can also be processed. The only requirement is that the geometric properties of the tube be coded according to this standard (and that the dimensions of the tube are within the physical feasibility of the processing equipment).

  According to embodiments, the tube data includes one or more of the following sample tube geometric properties. The outer diameter of the tube, the inner diameter of the tube, the position and shape of the false bottom, the length of the tube, the diameter of the tube cap, the free height of the tube cap.

  Geometric properties can be defined in various ways. According to one embodiment, the geometric characteristic can be defined in an incremental manner, for example. The upper or lower limit of the geometric property (ie, the maximum or minimum geometric property that the tube type can have for processing by the system, eg, the inner diameter of the tube or the length of the tube) It is known by the reader of the sample tube processing system that can read the geometric properties from the label. Instead, this limit is known to processing units or computing units that are connected to the sample processing system and receive tube data including geometric properties from the reader. As used herein, “to be known” for a member means that the data is stored in a data storage device that is accessible and readable by the member. The geometric property increment is encoded into the tube label. Geometric property values for individual tubes are determined by a reader, calculation unit, or processor by adding an increment to the limit (if lower limit) or subtracting an increment from the limit (if upper limit) Is done.

  In other embodiments, the geometric data value itself is stored as a numerical value in the tube label. This number does not give a unit in the tube data, this number is read by the reader and then as a specific unit value, for example millimeters. Similarly, this numerical unit can also be stored on the tube label.

  Furthermore, there can be a convention for the type of geometric property encoded in the tube label. This type of geometric characteristic may be based, for example, on the position of the data value in the tube label and / or on the position in a string or data pattern included in the tube label. For example, a first position in a series of numbers may include a value that identifies an "inner diameter" that is a geometric property value type, and a second position is a geometric property value type. A value specifying “the length of the tube” or the like may be included. Also, the type of geometric property is given to the tube label along with the value of the geometric property.

  Table 1 shows an example of the above-described code scheme. Var2 is an incremental geometric characteristic given the minimum and maximum values of some geometric features. The tube label holds the increment of the tube to which the tube label is attached and the actual structure is determined by adding the increment to the minimum value. In the example shown, the increment is 1, but can be an integer multiple of 1. Var3 gives the geometric parameter as an integer value, and the reader determines the type of geometric property indicated by the numerical value by the position of the numerical value in consecutive numbers. In Var4, an alphanumeric header is provided in addition to the numerical value representing the type of geometric property indicated by the corresponding numerical value. Table 1 also shows the number of bits required to encode each piece of information. Var2 requires 21 bits (3 bytes), while Var3 requires 10 bits and Var4 requires 15 bytes on the label.

  Table 2 shows the label size for the two-dimensional bar code necessary for encoding the data of the modified example. In addition to geometric data, the space required for a unique tube ID is also considered. It can be seen that the resulting label size corresponds well with the available space on the sample tube. These sized labels can be read by a conventional two-dimensional bar code reader, even if applied to a cylindrical sample tube.

  According to an embodiment, the processing apparatus comprises a gripper having an open position for receiving or releasing a sample tube or sample cap and a grip position for gripping the sample tube or sample cap, wherein at least the grip position is at least one grip position. It is adjusted according to geometric characteristics. In some embodiments, the gripper is a tube gripper or a cap gripper. The system also includes any combination of one or more tube grippers, cap grippers, or other forms of grip devices that are controlled according to the geometric data specified in the tube label. be able to. For example, the open position may be the initial position of the robot grip arm. According to some embodiments, both the open position and the grip position are adjusted according to geometric characteristics. To release the tube, it may be advantageous to use an open position in which the grip arm diameter is slightly larger than the diameter of the tube cap. If the next sample tube to be processed has the same or similar cap diameter as the previously processed tube, the grip arm would be able to adjust the grip diameter more quickly. As used herein, the term “position” should also be considered as any arrangement or state of a robotic device or device component used to interact with and / or process a sample tube. “Grip position” is a state or arrangement in which processing steps can be performed, while “open position” is a state or arrangement in which the sample tube can be released for further processing by other device components. It is.

  Tube data will allow the gripper to automatically determine where and how to grip the tube, and what cap is the capper or de-capper Will be able to determine whether the is attached to the tube and adjust the cap mechanism or cap removal mechanism accordingly.

  According to an embodiment, the processing device is a cap removal member or a re-capper with a tube gripper and a cap gripper. The tube gripper is controlled according to the geometric properties of the shape of the sample tube, and the cap gripper is controlled according to the geometric properties of the tube cap.

  According to an embodiment, the tube gripper comprises a first tube grip device and a second tube grip device, the first tube grip device being biasable with respect to the second tube grip device, and the second tube grip Collaborate with ingredients. For example, before the second tube gripping device grips, the first tube gripping device grips and lifts the tube from, for example, a conveyor belt or rack. By such an order, it can be achieved that the second gripper grips with a greater force and contact surface than the force and contact surface of the first gripper. This double grip mechanism allows the side wall of the tube to be gripped by smaller grip means in the narrow space between the common tube carrier and the closure member, resulting in a larger and stronger gripper for a safer grip The tube can be lifted to a height that can grip the longer part of the side wall.

  According to an embodiment, the processing device is an automatic centrifuge having a mounting station for placing the sample tube on the centrifuge. The loading station includes a gripper that is controlled to place the sample tube in the centrifuge bucket in response to the read geometric tube data. This may be advantageous because in some cases a similar or identical centrifugation program can be applied to many different biological samples housed in different tube types. If the diameters and weights of the different sample tubes containing each sample are approximately equal, a centrifugation step is provided by mounting them together in one and the same centrifuge, based on common geometric tube data. The efficiency of the sample manipulation workflow can be improved.

  According to an embodiment of the invention, the geometric data is used to determine the weight of the loaded sample. The determined weight is again used to load approximately equal weight samples into the centrifuge buckets that are in opposition to each other. In other words, the geometric data identified by the tube labels of the plurality of sample tubes is evaluated to automatically distribute the sample tubes so that they are balanced within the centrifuge bucket. Mounting to be balanced with the centrifuge includes cases where the sample tubes placed in opposing buckets in the centrifuge rotor are roughly the same, thus preventing the centrifuge from becoming unbalanced. it can. According to this embodiment, the weight can be obtained by geometric data specifying the inner diameter of the tube combined with the measured weight of the tube containing the sample.

  According to another embodiment, mounting on a centrifuge to be balanced can be accomplished without even the aid of a scale by performing the following steps. This includes determining the level of sample filling in the sample tube by means of a sensor or other optical reader, and a tube geometry that allows the reader to calculate at least the internal volume of the tube from the tube label of the sample. Reading geometrical data indicative of geometric characteristics. This characteristic can be, for example, the diameter of the tube, preferably the inner diameter of the tube. The approximate inner volume of the tube can also be calculated by the outer diameter. The determined filling level and the read geometric data indicating the geometric characteristics are used as input to calculate the actual volume of the sample contained in the sample tube. Assuming the density of all samples is the same or nearly the same for all samples, approximately equal volume samples are treated as approximately equal weight samples and automatically loaded into the opposite buckets of the centrifuge rotor. Is done. If collective centrifugation of significantly different density samples is scheduled, in additional steps, to calculate the sample weight from their respective volumes and densities, and approximately in the opposing buckets of the centrifuge Density is used as an additional input parameter to load equal weight samples. Density information may be specified in the tube label, according to some embodiments. This feature is a balanced, fully automated method that does not require additional equipment components (scale) and does not waste time to perform the physical weighing step Enables the installation of a centrifuge at

  According to an embodiment, the sample tube has a screw cap. Tube data includes tube cap data indicating the number of revolutions required to remove the screw cap from the sample tube. The processing device is a cap removal member with a cap gripper, which is controlled to rotate the screw cap at the number of revolutions indicated by the read tube cap data.

  According to an embodiment, the method further determines the approximate weight of the empty sample tube by using the read geometric properties or by reading the weight of the empty sample tube from the tube label by the reader. A step of determining, a step of measuring the weight of the sample tube containing the biological sample, and a step of determining a weight difference between the empty sample tube and the sample tube containing the biological sample.

  The determination of the approximate weight of an empty sample tube using the read geometric properties is the material of the sample tube, for example by using the inner and outer diameters of the sample tube and the height of the tube as inputs. A step of calculating the volume of the glass or resin material may be included. Given the calculated volume, given the density of the glass or resin product used, the weight of the tube is calculated. According to other embodiments, the weight of the sample tube may be specified in the tube data. For example, first weight information indicating the weight of an empty sample tube is read from the tube data. Then, the weight of the tube containing the whole blood sample is measured, and second weight information is obtained. The difference between the first and second weight information indicates the weight of the sample.

  According to some preferred embodiments, the method further comprises determining the fill level of the sample tube by using the difference in the weight of the sample tube and the geometric properties. For example, from the known density of a particular sample type, such as whole blood, and from the determined sample weight, the volume of the whole blood sample can be calculated, for example, in milliliters. By reading another geometric characteristic of the sample tube, in particular its inner diameter, the filling level of the sample tube can be calculated. This feature enables automatic and reliable determination even when the surface of the sample tube is covered with moisture, ice, or other substances that hinder fill level determination based on image analysis. Is advantageous. Depending on the determined filling level, another sample processing unit can dispense the sample without sucking in the elements of the centrifuge pellet, and without accidentally sucking in air with the pipette tip located on the sample meniscus. Can do.

  According to an embodiment, the reader is an optical reader or an RFID reader.

  According to an embodiment, the tube label comprises an optically readable pattern such as a barcode, in particular a two-dimensional barcode.

  A “bar code” is a machine-readable display of optical data. The barcode may be a one-dimensional barcode or a two-dimensional barcode, for example. A linear bar code comprises a series of parallel lines of varying width and spacing. A two-dimensional barcode may include rectangles, polygons, or other geometric patterns in two dimensions. Data stored in the bar code is read by an optical reading device called a scanner.

  Using a two-dimensional barcode allows the information density, that is, the amount of information per sample tube surface area, to store all of the information needed to properly handle a particular sample tube type. Is advantageous. For example, a two-dimensional barcode that specifies the exact height and wall thickness of a sample tube can greatly reduce dead volume. In another advantageous embodiment, the two-dimensional barcode is particularly strong in terms of gamma irradiation, which is commonly used by tube manufacturers to sterilize manufactured and typically already packaged sample tubes. . In an embodiment, a 5 mm × 5 mm bar code indicates that all geometric data required for the cap removal unit or cap unit to automatically and accurately cap or recap the sample tube. It has.

  According to some embodiments, the two-dimensional barcode is a data matrix code. The data matrix code is a square two-dimensional barcode having a plurality of square-shaped code elements scattered on a square-shaped area, and the scattered code elements specify the data content of the data matrix code.

  According to embodiments, the scanner reads an optically readable pattern and transmits this pattern to the image analysis component in the form of image data, eg, jpg or other image format. This transmission may be a push type or a pull type. The image analysis component may be part of a scanner (ie, part of a reading device), part of a processing device, or part of a software component connected to the scanner and / or processing system. The software component may be a laboratory middleware component or a laboratory laboratory information system (LIS) module. Image analysis evaluates this pattern to determine the geometric properties of the tube encoded therein.

  According to an embodiment, an antenna is attached to the sample tube. The tube label comprises a transmitter that sends tube data via an antenna.

  According to an embodiment, the tube label comprises an RFID circuit, in particular a polymer printed electrical circuit. Using an RFID circuit means that the reading of data from the chip occurs by freezing the sample, or by moving the frozen or cooled sample to a warm and humid environment, surface ice and condensation water This is advantageous because it is particularly strong against the effects of optical distortion. The use of polymer electronic circuits is such that these types of circuits are resistant to optical distortion effects and also to damage caused by gamma irradiation applied during sample tube sterilization, Particularly advantageous.

  According to embodiments, the tube data is printed or attached to the sample tube by the tube manufacturer before the manufacturing process is complete and the tube is sterilized.

  According to an embodiment, the sample tube is a raised bottom tube and the tube geometric tube data further includes the raised bottom geometric properties, in particular the presence and / or position of the raised bottom within the tube shaft. Raised bottoms are often used for smaller liquid volumes when the outer shape of the tube should be compatible with normal processing tools. A processing unit that pipettes liquid into such a raised bottom tube or draws liquid from the raised bottom tube automatically to avoid perforating the bottom and to minimize dead volume Automatically taking such bottom positions into account. Therefore, identifying the geometric properties of the raised bottom tube is advantageous because, in addition to the “conventional bottom tube”, the data allows full automation and safe operation of the raised bottom tube. According to an embodiment, the reader evaluates the tube data for any specification of raised bottom geometric properties. If the reader, controller or any other system component automatically determines the fill level from the geometric data, the raised bottom geometric property is added to accurately calculate the fill level for the raised bottom Adopted as information.

  According to an embodiment, the tube data includes information about the presence of a separating gel layer and optionally information about the position, cap design (Hemoguard®), Sarstedt®, screw cap And / or information about tube type identifiers.

  According to another embodiment, the tube label further comprises a pattern that changes when acceleration force (g-force) is applied for a minimum period of time and / or when the strength of the minimum acceleration force is exceeded. According to this embodiment, an existing acceleration force sensitive pattern, eg, another barcode section of the tube label, may be destroyed as a result of the acceleration force being applied. Alternatively, the new pattern may become visible in a region of the tube label that is pre-uniformly colored when an acceleration force is applied, or the pre-existing pattern in that region may change. Such an acceleration force sensitive tube label region is described, for example, in EP-A-2397225, which is hereby incorporated by reference in its entirety. This acceleration force sensitive pattern can also represent other forms of two-dimensional code, such as a matrix code.

  These features may be advantageous because camera-based decisions about sample tube rotation / non-rotation conditions tend to be error prone. By including an accelerating force sensitive label region in the sample tube, the static tube geometry is combined with dynamic changes in information about the tube state (rotated / non-rotated), resulting in a fully automated sample For operation, both types of data are made accessible to a reading device such as a barcode reader. This prevents errors that occur in prior art systems when rotating and non-rotating samples are pre-classified manually or by camera. In another advantageous aspect, a system that already includes an optical reader, such as a barcode scanner, does not require a separate hardware component for determining the tube rotation / non-rotation status.

  According to an embodiment, the plurality of sample tubes are operated by a processing device, and at least one geometric characteristic of each of the sample tube types is any value within a predetermined range, regardless of the predetermined sample tube type. Have

  This is advantageous because some sample tube processing steps do not depend on the scheduled sample processing step (eg specific analysis) or sample type, but only on some geometric properties. Will. For example, to determine whether a particular sample tube diameter or cap diameter is within a range of tube diameters or cap diameters that can be processed by a particular cap-capping member or cap-removing member, The sample classification unit can use the geometric properties of the read sample. Thus, all samples can be classified into groups of samples based on diameter range. This allows all samples in each group to be processed by a member that caps or removes a cap. Many cap-capping members or cap-removing members comprise a robotic grip arm for capping and / or removing the sample tube and are characterized by a minimum and maximum grip arm diameter. The classification unit described above can be used to flexibly classify multiple sample tubes with different tube diameters or cap diameters, depending on the requirements of the capping member or cap removing member available. Thereby, the sample processing can be fully automated and at the same time highly flexible.

  In another aspect, the invention relates to a sample tube having a tube label. The sample tube holds tube data, the tube data comprising at least geometric tube data representing at least one geometric characteristic of the sample tube.

  In another aspect, the invention relates to a system for processing a sample tube, the sample tube containing a biological sample. At least one sample tube has a tube label attached to the sample tube, the tube label holding tube data. The tube data comprises at least geometric tube data representing at least one geometric characteristic of the sample tube. The system comprises a reading device for reading at least geometric tube data from a tube label and a processing device for operating a sample tube with a control device, wherein the reading device transfers the geometric tube data to the control device. Connected to the input processing device, the control device can control the processing device in accordance with geometric tube data.

  According to an embodiment, the processing device is a device for removing a cap, a recap device, a cap holder or an automatic centrifuge.

  According to an embodiment, the system further comprises a sample tube. Each of the sample tubes is attached with a tube label that carries the tube data, and each of the sample tube tube data comprises at least geometric tube data representing at least one geometric characteristic of the sample tube. ing.

  Hereinafter, embodiments of the present invention will be described in more detail by way of example with reference to the drawings.

6 shows a flowchart of a method for automatically operating a sample tube containing a biological sample. 1 schematically shows a system comprising a plurality of sample tubes, a reading device and a processing device. A sample tube containing a bar code label is shown. 1 shows a sample tube containing an RFID circuit. The various parts of the sample tube are shown. 1 schematically shows a system comprising a plurality of sample tubes, a reader and other processing devices.

  FIG. 1 shows a flowchart of a method for automatically operating a sample tube 212 containing a biological sample. In a first step 102, at least geometric tube data 210 is read from the tube label by the reader 202. A tube label is attached to the sample tube. For example, the tube label may be an imprint printed on the surface of the sample tube during the manufacturing process. Similarly, the tube label can be applied to the surface of the sample tube after the sample tube has been manufactured, for example by an adherent. The tube label holds tube data, including at least geometric tube data, representing at least one geometric characteristic of the sample tube. In a further step 104, the geometric tube data read by the reader is transmitted from the reader to the processor 218. In step 106, the processing device is controlled in response to at least one geometric characteristic represented in the read geometric data. For example, this control step determines which gripping position the robot gripper 216 should use to remove the sample tube cap based on the cap diameter identified in the read geometric data. be able to.

  FIG. 2 schematically illustrates a sample manipulation system 200 that includes a plurality of sample tubes 214, a reader 202, and a processor 218. The plurality of sample tubes of different tube types includes biological samples of different sample types. The sample tube is moved relative to the processing device. The sample tube is selectively held on a tube carrier, which may be a single tube carrier, so-called “puks”, or a multi-tube carrier, so-called “tube racks”. It may be. The multi-tube carrier includes a plurality of receptacles that accept, for example, up to five, or more than six tubes, typically to receive different tube types, i.e. tubes having various diameters and heights. It is configured. According to the illustrated embodiment, the processing system (cap removal device) comprises a tube conveyor belt configured to move a sample tube on a single tube carrier and / or tube rack (not shown). . This conveyor belt is driven by a motor and is transported like an auxiliary transfer band or auxiliary transfer guide, which is arranged to move the pipe in stages to move the pipe in line with the cap removal station at once. A unit may be provided. This transfer unit may be configured to move a tube on a special carrier, or conversely may be customized according to the requirements of the processing equipment. In certain embodiments (not shown), reformatting devices that transfer sample tubes for pax and / or tube racks to these special carriers may be operably coupled to the processing device.

  The multiple samples reach the input position of the system and are transferred by conveyor belt 208 to a “read position” where the label of each sample can be read by the reader 202. The reading device 202 reads at least geometric tube data displayed on the tube label and sends the read tube data to a controller 204 that is part of the processing device 218. According to an embodiment, the reading device can be a scanner that can read optical data, such as a two-dimensional code, from the tube label 210 of the sample tube 212. According to other embodiments, the reader 202 may be an RFID reader that can read data from an RFID circuit 308.2 that is part of the label 210 of the sample tube. The processing device 218 includes a robot unit 216 that executes workflow steps in the sample tube 212. Depending on the embodiment, the processing device 218 may be a unit of a pre-analysis sample manipulation system, an analysis sample manipulation system or a post-analysis sample manipulation system, or as a complete pre-analysis work cell, analysis work cell, post-analysis work cell. Also good. The robot unit may be a gripper that is controlled by the controller 204 in response to tube data received from the reader 202 by the controller. The gripper may be part of the grip unit.

  According to the illustrated embodiment, the processing device is a cap removal device that automatically removes the cap of the mounted sample tube. For example, the gripper 216 can remove different tube caps having different diameters, cap heights, surface textured caps, and the like.

In the illustrated embodiment, the gripper is a robotic arm with an open position 220 for receiving and / or releasing the sample tube and a grip position 222 for gripping the sample tube. At least the grip position is adjusted according to at least one geometric characteristic of the sample tube.

According to an embodiment, the gripper 216 is a robotic grip arm that can dynamically adjust the grip arm diameter to the tube cap diameter specified by the received tube data. The grip arm, in the “open position”, has a specific initial diameter and assumes that the diameter does not exceed the physical default maximum or minimum diameter of the gripper 216 and the diameter of the cap of the sample tube. It can be enlarged or reduced until By adjusting the grip arm diameter to the read cap diameter, the gripper 216 can process each of a plurality of different sample tubes 214 having different cap diameters. In some embodiments, the gripper can dynamically adjust its vertical and / or horizontal position within the grip unit 206 depending dynamically on the geometric data of the sample tube. Therefore, dynamically adjust for different tube heights, different tube cap heights, different cap textures (smooth or grooved etc.), different cap shapes (round or polygonal) etc. can do.

  According to an embodiment in which the label includes information on the number of revolutions required to cap or remove the sample tube, the number of revolutions specified in the tube label geometric data is applied to the tube cap. The gripper 216 can use this information to perform the cap removal step.

  FIG. 3a shows a sample tube 212 with a tube label 306 having a barcode 308.1. The sample tube includes a cap 302 which can be, for example, a press-lock or screw-type cap. The label 306 includes a bar code 308.1 and a human-readable label section. This tube label 306 can be imprinted or attached to the surface 304 of the sample tube. The bar code is a two-dimensional code that can be read by an optical reading device such as a scanner. The tube tube of the illustrated sample tube includes a tube neck 312 that is not found in other tube types.

  FIG. 3b illustrates a sample tube 212 corresponding to the sample tube of FIG. 3a, but with an RFID circuit 308.2 instead of a barcode as a tube label. Preferably, the RFID circuit 308.2 is a passive RFID circuit that receives energy via a sample tube and an antenna 314 attached to the RFID circuit. The corresponding reader is an RFID reader. An RFID reader or other device generates an electromagnetic field that acts as an energy source for the RFID circuit. When the RFID circuit moves into the electromagnetic field, the RFID circuit can obtain enough energy through its antenna 314 to send the tube data stored in the RFID circuit through the antenna to the RFID reader. .

  FIG. 4 illustrates various parts of the sample tube. The sample tube has a tube inner diameter 404 and a tube outer diameter 406. The height of the tube cap (which may cover some portion of the tube shaft) visible from the outside of the tube is referred to as the free height 408 of the tube cap. Although caps are not present in all tube types, all tubes are constructed of or include tube shafts having a specific tube shaft length. The length of the distance from the bottom of the tube to the top of the tube cap (or the top of the tube shaft in the case of a tube without a cap) is referred to herein as the tube length 414. The tube shaft length 410 of a tube without a cap is the same as the tube length. The outer diameter of the tube cap that can be seen from a bird's-eye view is called “cap diameter” 412.

  FIG. 5 schematically illustrates another automated sample handling system 500. This system includes a plurality of sample tubes 214, a reading device 202, and another processing device 514. The processing apparatus includes a tube grip unit 522 having a tube gripper 502, a cap removing unit 524 having a tube cap gripper 508, a pipette unit having a pipettor 516, and a recap unit 528 having a recap portion 518. . The processing device 514 is a fully automated sample work cell that can transfer a plurality of samples 214 by a conveyor belt 208 or other robotic transfer equipment. The tube gripper 502 is a robotic arm that is controlled according to the geometry of the sample tube, for example the outer diameter of the tube or the height of the tube, rather than the geometric properties of the tube cap (if any). It is. The controller can determine the position of the gripper arm of the tube gripper according to the geometric tube data received from the reader 202. Two different positions of the grip arm, the open position 506 and the grip position 504 are indicated by two dotted arrows. The cap gripper 508 of the cap removal unit 522 and the cap gripper 518 of the recap unit 528 are each controlled by a geometric characteristic of the cap of the sample tube, for example, the diameter of the cap or the free height of the cap of the tube. It is an arm. Some geometric properties of the tube, especially its height, can also be used by the cap gripper to dynamically adjust the vertical position of the cap gripper to the height of the cap of the tube. According to an embodiment, the tube gripper 502 positions the tube and the sample tube cap where the cap gripper 508 is positioned can be removed. When the cap is successfully removed from the sample tube, the pipettor 516 can draw a dispensed amount from the sample or pipette the reagent into the sample. According to embodiments, the volume that can be aspirated from or added to the sample tube 212 '' without touching the bottom of the tube and without too much liquid entering the sample tube. To calculate, the controller 204 uses at least some geometric data read from the sample tube label 210. The sample tube is then automatically sent from the pipette unit 526 to the recap unit 528, where a cap gripper 518 that can accommodate different grip diameters 530, 532 places a new cap on the sample tube 212 ''. The last sample tube 212 '' 'can be moved by a conveyor belt to a storage unit (not shown). The various sample processing units 522, 524, 526 and 528 can be part of the same or different hardware modules or inspection devices. The interaction between the tube gripper and the cap gripper is described in more detail, for example, in US Pat. No. 6,599,476 and US Pat. No. 5,819,508, which are hereby incorporated by reference in their entirety. Is done. An example of a tube gripper is given by US Pat. No. 5,819,508, FIG. 3 and the corresponding description. An example of a cap gripper is given by FIG. 5 and the corresponding description of the aforementioned document.

102 Step 104 Step 106 Step 200 Sample tube processing system 202 Reading device 204 Control device 206 Grip unit 208 Conveyor belt 210 Tube label 212 Sample tube 214 Multiple sample tubes 216 Gripper 218 First processing device 220 Open position 222 Grip position 302 Tube Cap 304 Tube surface 306 Tube label 308.1 Barcode 308.2 RFID circuit 310 Human readable data section 312 Tube neck 404 Tube inner diameter 406 Tube outer diameter 408 Tube cap free height 410 Tube shaft Length 412 Tube cap diameter 414 Tube length 500 Sample tube processing system 502 Tube gripper 504 Tube gripper grip position of tube cap unit 506 Tube cap unit 508 pipe gripper opening position 508 cap removal unit cap gripper 510 cap removal unit cap gripper opening position 512 cap removal unit cap gripper grip position 514 second processing unit 516 pipettor 518 recap unit cap gripper 522 tube Grip unit 524 Cap removal unit 526 Pipette unit 528 Recap unit 530 Cap gripper opening position of cap removal unit 532 Cap gripper grip position 212 of cap removal unit Sample tube 212 at various processing stages
212 '' Sample tube 212 at various processing stages
212 '''Sample Tube 212 at Various Processing Stages

Claims (16)

A method of operating a sample tube (212) containing a biological sample, wherein a tube label (210, 306) is attached to the sample tube, the tube label holds tube data, and the tube data is At least geometric tube data representing at least one geometric characteristic of the sample tube;
The method comprises
Reading (102) at least the geometric tube data from the tube labels (210, 306) by a reader (202);
Transmitting (104) at least the geometric tube data from the reader to a processor (218);
Controlling the processing device (218) operating the sample tube (212) in response to at least one geometric characteristic represented by the read geometric data ;
Determining an approximate weight of an empty sample tube by using the read geometric characteristic or by reading the weight of an empty sample tube from the tube label by the reader;
Measuring the weight of the sample tube containing the biological sample, and determining a weight difference between the empty sample tube and the sample tube containing the biological sample;
Determining the level of filling of the sample tube using the weight difference and the geometric property . The tube data is
Tube outer diameter (406), tube inner diameter (404), tube length (414), tube cap diameter (412), tube cap (302) free height (408), raised bottom position and The method according to claim 1, comprising geometric properties of one or more of the sample tubes of shape. The processing device comprises a gripper (216, 502, 508, 518), the gripper being in an open position (220, 506, 510, 530) for receiving or releasing the sample tube or the cap of the sample tube. And grip positions (222, 504, 512, 532) for gripping the sample tube or the cap of the sample tube, wherein at least the grip position is adjusted according to the at least one geometric characteristic. The method according to 1 or 2. The processing device is a member for removing a cap or a recap member provided with a tube gripper (502) and a cap gripper (508, 518), the tube gripper depending on the geometric characteristics of the shape of the sample tube 4. The method according to any one of claims 1 to 3, wherein the cap gripper is controlled in response to geometric characteristics of the cap of the tube. The processing apparatus is an automatic centrifuge having a mounting station for mounting a sample tube on a centrifuge, the mounting station has a gripper, and the gripper is in accordance with the read geometric tube data. Controlled to place the sample tube in a centrifuge bucket, the geometric tube data is used to determine the volume and / or weight of the loaded sample, and the determined volume or weight is The method according to any one of claims 1 to 3, wherein the method is used for loading samples of approximately equal weight or approximately equal volume in centrifuge buckets located opposite each other. The sample tube has a screw cap, and the tube data includes tube cap data indicating the number of revolutions required to remove the screw cap from the sample tube, and the processing device includes a cap gripper. A member for removing a cap provided, wherein the cap gripper is controlled to rotate the threaded cap at a rotational speed indicated by the read tube cap data. The method according to claim 1. The method according to any one of claims 1 to 6, wherein the reader is an optical reader or RFID reader. The tube label, A method according to any one of claims 1 to 7 including an optically readable pattern. The method of claim 8 , wherein the optically readable pattern is a barcode. The method of claim 9 , wherein the barcode is a two-dimensional barcode. Antenna (314) is attached to the sample tube, the tube label, A method according to any one of claims 1 to 10 comprising a transmitter for transmitting data of said tube through said antenna. The method of claim 11, wherein the tube label comprises an RFID circuit (310). The method of claim 12 , wherein the RFID circuit is a polymer printed electrical circuit. A plurality of sample tubes are operated by the processing device, and at least one geometric characteristic of each of the sample tube types has an arbitrary value within a predetermined range regardless of the predetermined sample tube type. The method according to any one of 1 to 13 . A system (200, 500) for processing sample tubes (214, 212), wherein the sample tube contains a biological sample, and at least one of the sample tubes has a tube label (306) attached to the sample tube. The tube label comprises tube data, the tube data comprising at least geometric tube data representing at least one geometric characteristic of the sample tube;
The system is
A reader (202) for reading at least geometric tube data from the tube label;
A processing device (218, 514) for operating the sample tube, comprising a control device (204),
In order to input the geometric tube data to the control device, the reading device is connected to the processing device, and the control device controls the processing device according to the geometric tube data. possible der is,
The processing apparatus is an automatic centrifuge having a mounting station for mounting a sample tube on a centrifuge, the mounting station has a gripper, and the gripper is in accordance with the read geometric tube data. Controlled to place the sample tube in a centrifuge bucket, the geometric tube data is used to determine the volume and / or weight of the loaded sample, and the determined volume or weight is A system used to load samples of approximately equal weight or approximately equal volume in centrifuge buckets located opposite each other . A sample tube (214, 212-212 ′ ″), the tube label being attached to each of the sample tubes, the tube label holding tube data, and the data of each tube of the sample tube being The system of claim 15, comprising at least geometric tube data representing at least one geometric characteristic of the sample tube.

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